A randomized controlled trial of continuous nitroglycerine Infusion with or without a preceding nitroglycerine bolus dose in older patients with acute heart failure.

Phase 3

Recruiting

• Conditions: itroglycerine bolus dose and follow by in fusion in emergency department older adults with hypertensive heart failure.; Nitroglycerine, older adults, hypertension, heart failure

• Registration Number: TCTR20230517007
• Lead Sponsor: avamindradhiraj University Research Fund

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2023-05-17
• Last Update Posted: 19 August 2024
• Study Completion: 2025-06-01

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 186

Inclusion Criteria

1. Patients over 65 years of age who come to the emergency room of Vajira Hospital
2. The patient was diagnosed with acute heart failure.
3. The patient has a systolic blood pressure greater than 140 mm Hg.

Exclusion Criteria

1. Have a history of allergy to nitroglycerin
2. Brain accident
3. Severe sepsis (SOFA score >=2, lactate >4, and there is evidence of a source of infection contributing to the symptoms that brought the patient to the emergency room).
4. Liver failure or chronic cirrhosis Stage 3-4 (decompensated liver cirrhosis)
5. Chronic renal failure or end-stage renal disease with a glomerular filtration rate (GFR) of less than 15 ml/min/1.73 m
6. ST elevation (STEMI) or right ventricular ischemia (RV infarction).
7. Having a history of drug use phosphodiesterase type 5 (PDE-5) inhibitors, including sildenafil, tadalafil, vardenafil, within 48 hours
8. Having a history of high intracranial pressure such as brain tumors, cerebral hemorrhage and assessed from other associated symptoms, including severe headache, Blurred vision, double vision, convulsions, depression, loss of consciousness, nausea, vomiting, sudden weakness of one limb.
9. Have a history of hypertrophic cardiomyopathy, restrictive cardiomyopathy
10. Have cardiac temponade
11. Chronic pericarditis (constrictive pericarditis)
12. Weighing less than 40 kilograms or more than 100 kilograms

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Time to first systolic blood pressure less than 140 mmHg 1 hour after received nitroglycerine Blood pressure measurement using Philips - IntelliVue MX400 every 5 minutes until 60 minutes,Delta change of systolic blood pressure 1 hour after received nitroglycerine Blood pressure measurement using Philips - IntelliVue MX400

Secondary Outcome Measures

Name	Time	Method
Accumulation dose of nitroglycerine 1 hour microgram,ICU admission 24 hours rate of ICU admission ,Mortality 30 days rate of mortality ,Intubation 24 hours Intubation rate